Self calibrating blood chamber

ABSTRACT

An optical blood monitoring system and corresponding method avoid the need to obtain a precise intensity value of the light impinging upon the measured blood layer during the analysis. The system is operated to determine at least two optical measurements through blood layers of different thickness but otherwise substantially identical systems. Due to the equivalence of the systems, the two measurements can be compared so that the bulk extinction coefficient of the blood can be calculated based only on the known blood layer thicknesses and the two measurements. Reliable measurements of various blood parameters can thereby be determined without certain calibration steps.

CROSS-REFERENCE TO RELATED APPLICATIONS

This patent application is a continuation of copending U.S. patentapplication Ser. No. 14/188,193, flied Feb. 24, 2014, which isincorporated herein by reference in its entirety.

FIELD

The present invention relates to blood monitoring systems forhemodialysis patients, and in particular, to methods of measuringhematocrit and/or estimating hemoglobin levels using a self-calibratingblood chamber. The same approach can be applied to measurement of otherparameters as well, such as oxygen saturation and or other analytelevels in the blood.

BACKGROUND OF THE INVENTION

Patients with kidney failure or partial kidney failure typically undergohemodialysis treatment in order to remove toxins and excess fluids fromtheir blood. To do this, blood is taken from a patient through an intakeneedle (or catheter) which draws blood from a vessel such as an arterylocated in a specifically accepted access location (for example, an arm,thigh, subclavian, etc.). The needle (or catheter) is connected toextracorporeal tubing that is fed to a peristaltic pump and then to adialyzer which cleans the blood and removes excess water. The cleanedblood is then usually returned to the patient through additionalextracorporeal tubing and another needle (or catheter). (In some cases,the blood may be returned to the body through the same extracorporealconnections as the intake—a mode called “single needle dialysis”).Sometimes, a heparin drip is located in the hemodialysis loop to preventthe blood from coagulating. By way of background, as the drawn bloodpasses through the dialyzer, it travels in straw-like tubes within thedialyzer which serve as semi-permeable passageways for the uncleanblood. Fresh dialysate solution enters the dialyzer at its downstreamend. The dialysate surrounds the straw-like tubes and flows through thedialyzer in the opposite direction of the blood flowing through thetubes. Fresh dialysate collects toxins passing through the straw-liketubes by diffusion and excess fluids in the blood by ultra filtrationwhile leaving the red cells in the blood stream, which cannot passthrough the straw-like tubes due to physical size.

For patients undergoing hemodialysis treatment, it is typical to monitorthe patient's blood using a blood monitoring system during thetreatment. For example, an optical blood monitoring system may be usedthat employs optical techniques to non-invasively measure, in real-time,the hematocrit level of blood flowing through the hemodialysis system.In such a system, a blood chamber may be attached in-line to theextracorporeal tubing usually on the arterial side of the dialyzer. Theblood chamber provides a viewing point for optical sensors during thehemodialysis procedure. Wavelengths of light are directed through theblood chamber and the patient's blood flowing there through, and one ormore photo detectors can be used to detect the resulting intensity ofeach wavelength. From the detected light intensity, a hematocrit valuecan be calculated and a hemoglobin level can be estimated.

BRIEF SUMMARY OF THE INVENTION

The present invention is directed to the use of an optical blood monitorincluding an optical blood sensor assembly and blood chamber that areconstructed in a manner that reduces the complexity of, or eliminatesthe need for, calibrating the blood monitor to account for variance inthe light intensity passing through the blood from one monitor to thenext. This is achieved by making two optical measurements through theblood, where all variables between the two measurements aresubstantially identical except the distance that the light travelsthrough the blood. A ratio of the two measurements can then be used todetermine the values needed to calculate certain blood parameterswithout requiring a precise value of the light intensity emitted throughthe blood. Accordingly, various calibration procedures that areordinarily required become unnecessary.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S)

Exemplary embodiments of the present invention are described in moredetail below with reference to the drawings, in which:

FIG. 1 shows a perspective view of a hemodialysis system that includes ablood monitor in accordance with an embodiment of the invention;

FIG. 2 shows a front view of a controller and display used with theblood monitor shown in FIG. 1;

FIG. 3 shows the geometry corresponding to calculations used in opticalblood monitoring;

FIG. 4 shows the effect of the structure surrounding the blood on thecalculations used in optical blood monitoring;

FIG. 5 shows a sample radiation pattern from a light source;

FIG. 6 shows a perspective view of an optical blood monitor sensor inaccordance with an embodiment of the invention;

FIG. 7 shows a cross sectional view of the optical blood monitor sensorof FIG. 6;

FIG. 8 shows a perspective view of a blood chamber in accordance with anembodiment of the invention;

FIG. 9 shows a cross sectional view of the blood chamber of FIG. 8; and

FIG. 10 shows a control system for operating a blood monitor inaccordance with an embodiment of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

FIG. 1 illustrates a patient 10 undergoing hemodialysis treatment usinga hemodialysis system 12, as well as a non-invasive, optical bloodmonitor 14. An input needle or catheter 16 is inserted into an accesssite of the patient 10, such as in the arm, and is connected toextracorporeal tubing 18 that leads to a peristaltic pump 20 and then toa dialyzer or blood filter 22. The dialyzer 22 removes toxins and excessfluid from the patient's blood. The dialysized blood is returned fromthe dialyzer through extracorporeal tubing 24 and return needle orcatheter 26. Excess fluids and toxins are removed by clean dialysateliquid which is supplied to the dialyzer 22 via tube 28 and removed fordisposal via tube 30. A typical hemodialysis treatment session takesabout 3 to 5 hours in the United States.

The optical blood monitor 14 includes a blood chamber 32, an opticalblood sensor assembly 34, and a controller 36. The blood chamber 32 ispreferably located in line with the extracorporeal tubing 18 upstream ofthe dialyzer 22. Blood from the peristaltic pump 20 flows through thetubing 18 into the blood chamber 32. The preferred sensor assembly 34includes LED photo emitters that emit light at substantially 810 nm,which is isobestic for red blood cell hemoglobin, substantially 1300 nm,which is isobestic for water, and at substantially 660 nm, which issensitive to the oxygenation of hemoglobin. The blood chamber 32includes lenses so that the sensor emitters and detectors can view theblood flowing through the blood chamber 32, and determine the patient'sreal-time hematocrit value and oxygen saturation value using ratiometrictechniques generally known by those of ordinary skill in the art.

FIG. 2 is a front view of a controller 36 for the optical blood monitor14. The controller 36 includes a display 100 which provides real-timeblood monitoring data for the patient undergoing hemodialysis. Thedisplay in FIG. 2 illustrates the amount of time 102 that the patient 10has been monitored while undergoing hemodialysis for the currenttreatment session. The display 100 also illustrates real-time values forthe optically monitored hematocrit (HCT) 104 and oxygen saturation (SAT)level 106, as well as calculated values for hemoglobin (HGB) 108 andchange in blood volume (BVΔ) 110 during the treatment session. The graph112 on the display 100 illustrates the change in the patient's bloodvolume over the course of the 2 hour and 53 minute treatment session.(Other variants of the graph 112 are possible such as showing a dualgraph (upper and lower) with one displaying change in patient's bloodvolume and the other the patient's oxygen saturation.) These data areoften displayed, as shown in FIG. 1, in a location that is locatedwithin the vicinity of the patient 10. These data can also be displayedat a central monitoring location via a wired or wireless system.Techniques that are used to obtain the values shown on display 100 areknown to those of skill in the art. Certain aspects of these methods areparticularly relevant to the methods and systems of the presentinvention and are described in further detail in the following.

LED emitters corresponding, for example, to the wavelengths describedabove, along with respective photodetectors for the optical bloodmonitor are positioned in place in the vicinity of the blood chamber.The wavelengths of light are directed through the blood chamber and thepatients Hood flowing through the chamber so that the correspondingphotodetector, typically the opposite side of the blood, can detect theresulting intensity of each wavelength. A ratiometric technique,substantially as disclosed in U.S. Pat. No. 5,372,136 entitled “Systemand Method for Non-Invasive Hematocrit Monitoring”, which issued on Dec.13, 1999 and is assigned to the assignee of the present application,uses this information to calculate the patient's hematocrit value inreal-time. The hematocrit value, as is widely used in the art, is thepercentage determined by dividing the volume of the red blood cells in agiven whole blood sample by the overall volume of the blood sample.

In a clinical setting, the actual percentage change in blood volumeoccurring during hemodialysis can be determined, in real-time, from thechange in the measured hematocrit. Thus, an optical blood monitor isable to non-invasively monitor not only the patient's hematocrit levelbut also the change in the patient's blood volume in real-time during ahemodialysis treatment session. The ability to monitor real-time changein blood volume helps facilitate safe, effective hemodialysis.

The mathematical ratiometric model for determining the hematocrit (HCT)value can be represented by the following equation:

$\begin{matrix}{{HCT} = {f\lbrack \frac{\ln ( \frac{i_{\lambda 2}}{I_{0 - {\lambda 2}}} )}{\ln ( \frac{i_{\lambda 1}}{I_{0 - {\lambda 1}}} )} \rbrack}} & (1)\end{matrix}$

where i_(λ2) is the infrared light intensity detected by thephotodetector at about 810 nm, i_(λ1) is the infrared intensity detectedat 1300 nm and I_(0-λ2) and I_(0-λ1) are constants representing theinfrared light intensity incident on the blood accounting for lossesthrough the blood chamber. The function f[ ] is a mathematical functionwhich has been determined based on experimental data to yield thehematocrit value. Preferably, the function f[ ] in the above Equation(1) is a relatively simply polynomial, e.g. a second order polynomial.The above Equation (1) holds true only if the distance traveled by theinfrared light radiation from the LED emitters to the photodetectors atboth wavelengths are constant distances and preferably the samedistance.

The preferred wavelengths to measure oxygen saturation level are about660 nm and about 810 nm. The mathematical ratiometric model fordetermining oxygen saturation level (SAT) can be represented by thefollowing equation:

$\begin{matrix}{{SAT} = {g\lbrack \frac{\ln ( \frac{i_{\lambda 3}}{I_{0 - {\lambda 3}}} )}{\ln ( \frac{i_{\lambda 1}}{I_{0 - {\lambda 1}}} )} \rbrack}} & (2)\end{matrix}$

where i_(λ3) is the light intensity of the photodetector at 660 nm, inis the detected intensity at 810 nm and I_(0-λ3) and I_(0-λ1) areconstants representing the intensity incident on the blood accountingfor losses through the blood chamber. The function g[ ] is amathematical function determined based on experimental data to yield theoxygen saturation level, again preferably a second order polynomial.Also, like Equation (1) for the hematocrit calculation, Equation (2) forthe oxygen saturation level calculation holds true only if the distancetraveled by the visible and infrared light from the respective LEDemitter to the respective photodetector at both the 660 nm and 810 nmwavelengths are constant distances and preferably the same distance.

The above ratiometric models use constants to account for loss throughthe blood chamber to determine the light incident on the blood. The moregeneral evaluation of light through the blood, or any other component ofthe optical system, is based on Beers Law, which is demonstrated by FIG.3 and is set forth as follows with specific regard to a blood layer:

i=I _(o) e ^(−αd)  (3)

where: I=the intensity of the received signal of the light after passingthrough the blood,

-   -   I_(o)=the impressed amplitude of the light wave as it enters the        blood,    -   α=the bulk extinction term including the extinction coefficient        of the blood and the concentration of the blood in the volume        under test, and    -   d=the distance the light travels through the blood layer being        tested.

As illustrated in FIG. 3, the light enters the volume of blood that isbeing examined from one side with an intensity of I_(o), passes throughthe blood 2 after travelling a distance d, and emerges from the volumeof blood 2 with an intensity, i. In the idealized model shown in FIG. 3,the bulk extinction term α can be easily determined, from whichhematocrit and oxygen saturation values can be determined by methodsknown to those of skill in the art. However, as illustrated by FIG. 4,obtaining the amplitude of the light that enters the volume of bloodwithin the blood monitoring chamber is not trivial. Each of the elementsin the optical path between the light emission element 4 and the lightsensor 8 must be accounted for in the analysis. In the exampleillustrated in FIG. 4, these elements include a layer of epoxy 3disposed over each of the light emission element 4 and the light sensor8, a lens 5 disposed on each side of the blood chamber 32, each of theblood chamber walls 6, and air gaps 7 on either side of each lens. Thus,the evaluation of the complete optical path includes the application ofBeers Law for each of these ten components as well as the blood itself.

The foregoing eleven different applications of Beers Law can be combineddue to the evident relationship of the received and emitted light ateach boundary. Specifically, because the light being emitted from onelayer is the same as the light being received at the subsequent layer,these terms are equal and thus, can be substituted for one another. Anexample of the combining of the application of Beers Law for two layersis illustrated by equations (4) through (6). Equation (4) is arepresentation of Beers Law for the intensity of the light i_(a1) beingemitted from the first air gap 7 shown in FIG. 4. As shown in equation(4), the light emitted from the first air gap i_(a1) is a functionaccording to Beers Law of the light received at the air gap I_(oa1).

i _(a1) =I _(oa1) e ^(−α) ^(a) ^(d) ^(a1)   (4)

where: i_(a1)=the intensity of the light after passing through the firstair gap,

-   -   I_(oa1)=the impressed amplitude of the light wave as it enters        the first air gap,    -   α_(a)=the bulk extinction term for the first air gap, and    -   d_(a1)=the distance the light travels through the first air gap.        Further, as shown in FIG. 4, and stated previously, the light        being received at the air gap I_(oa1) is the same as the light        being emitted from the epoxy i_(e), which can be expressed as a        function of the light emitted from the light source I_(oL), as        shown in equation (5),

I _(oa1) =i _(e) =I _(oL) e ^(−a) ^(e) ^(d) ^(e1)   (5)

where: i_(e)=the intensity of the light after passing through the firstepoxy layer,

-   -   I_(oL)=the impressed amplitude of the light wave as it enters        the first epoxy layer,    -   α_(e)=the bulk extinction term for the first epoxy layer, and    -   d_(e)=the distance the light travels through the first epoxy        layer.        Accordingly, by substituting the function from equation (5) into        the unknown value for I_(oa1) in equation (4), the intensity of        the light being emitted from the first air gap i_(a1) can be        expressed as a compound form of Beers Law, yielding equation        (6), where the intensity of the light after the first air gap is        expressed as a function of the light from the light source and        the constants related to the epoxy layer and air gap, as        follows:

i _(a1)=(I _(oL) e ^(−α) ^(e) ^(d) ^(e1) )e ^(−α) ^(a) ^(d) ^(a1)   (6)

The foregoing substitution can be applied for all eleven components inthe optical path to arrive at a single equation for the intensity of thelight received at the detector i_(d) based on the emitted light from thelight element I_(oL). This single equation (7) is shown below, whereeach of the ten optical components has been represented with a numericalreference except for the blood layer component (e^(−αbdb)), as follows:

i _(d) =I _(L) [e ^(−α1d1) e ^(−α1d1) e ^(−α3d3) e ^(−α4d4) e ^(−α5d)(e^(−αbdb))e ^(−α6d6) e ^(−α7d7) e ^(−α8d8) e ^(−α9d9) e ^(−α10d10)]  (7)

The static components of the optical path are substantially invariablewith respect to time, and thus their contributions can be consideredconstant. As such, equation (7) can be rewritten with all of thecomponents of the epoxy layers, air gaps, lenses and chamber walls beingrepresented by a single constant value A, as shown in equation (8).

i _(d) =I _(oL) Ae ^(−αbdb)  (8)

Moreover, since the intensity of the light emitted by the light emissionelement is consistent from one reading to the next, the constant A canbe combined with the emitted light intensity I_(oL) into a modifiedlight intensity I_(oT) as shown in FIG. (9).

i _(d) =I _(oT) e ^(−αbdb)  (9)

Thus, as illustrated by equation (9) the intensity of the receivedsignal at the light sensor varies based solely on the bulk extinctioncoefficient for the blood α_(b) for a given thickness of the measuredblood and can be calculated so long as I_(oT) is known.

However, calculating I_(oT) is not trivial, as it is based on the bulkextinction coefficient of each of the optical components disposed in theoptical path from the light emission element 4 to the light detector 8.In view of the large number of components disposed between the emissionelement 4 and light detector 8, small variances in each thesecomponents, based merely on manufacturing tolerances, cause uncertaintyin the value of I_(oT) from one blood monitor to the next. To addressthese variances, blood monitors are typically calibrated and thenvalidated in a laboratory using actual human blood from a blood bank todetermine the appropriate constants for use with each particular bloodmonitor. This process is long, laborious and expensive, and attainingblood can be difficult.

The present invention is directed to an optical blood monitoring systemand corresponding method that avoid the need to obtain a preciseintensity value of the light impinging upon the blood layer. This isachieved by taking at least two optical measurements through bloodlayers of different thickness but using the same light source for eachmeasurement. Due to the difference in thickness, each of themeasurements can be represented by a different equation, where the termsfor the blood layer thickness and the received signal differ. However,the terms for both the intensity of the light impinging upon the bloodlayer and the bulk extinction coefficient of all the optical elements inthe system, aside from the blood, are the same in both models. For thisreason, the two equations can be combined and the redundant terms can beremoved in order to solve for the bulk extinction coefficient of theblood based only on the known blood layer thicknesses and thecorresponding two measurements.

In an embodiment, the present invention provides a blood monitor with alight emission element that projects light along two identical opticalpaths but through blood layers of different thickness. Each path isdirected to a respective light sensor that measures the intensity of thelight that has passes through the respective blood layer thickness.Preferably, the positions of the two optical paths are situated suchthat the intensity of the impressed light from the light emissionelement is the same along both paths. Consequently, so long as the othercomponents in the blood monitor optical paths are constructedsubstantially identically, the intensity of the light being directedinto the blood layer along each path will be substantially identical.The components for receiving light intensity are equal in sensitivityand are integrated into equal optical paths for measurement of the lightafter blood penetration for each of the two path measurements. Thisequivalence allows the components representing the received lightintensity to be removed from a mathematical model that is representativeof a combination of the two measurements, as explained in detail below.

As already described, light passing through a layer of blood ofthickness d can be represented by equation (9). Thus, two optical paths,passing through blood layers of thickness d_(b1) and d_(b2) can berepresented by equations (9a) and (9b), where the measured signals willdiffer due to the difference in only the blood layer thickness.

i _(d1) =I _(oT) e ^(−αbdb)  (9a)

i _(d2) =I _(oT) e ^(−αbdb)  (9b)

Dividing (9a) from (9b) allows the equations to be combined, so that thelight impingement term I_(oT) is included in both the numerator anddenominator and can therefore be removed, as shown in equation (10)

$\begin{matrix}{\frac{i_{d\; 1}}{i_{d\; 2}} = {\frac{I_{oT}^{{- \alpha_{b}}d_{b\; 1}}}{I_{oT}^{{- \alpha_{b}}d_{b\; 2}}} = {^{{{- \alpha_{b}}d_{b\; 1}} + {\alpha_{b}d_{b\; 2}}} = ^{\alpha_{b}{({d_{b\; 2} - d_{b\; 1}})}}}}} & (10)\end{matrix}$

Taking the natural log of equation (10) allows the bulk extinctioncoefficient of the blood α_(b) to be isolated and determined based onlyon the measured signals and respective blood thicknesses withoutrequiring a value for the light impingement term, as shown in equation(11).

$\begin{matrix}{\alpha_{b} = \frac{\ln ( \frac{i_{d\; 1}}{i_{d\; 2}} )}{( {d_{b\; 2} - d_{b\; 1}} )}} & (11)\end{matrix}$

Based on equation (11) it can be seen that the difference in thicknessbetween the two measured blood layers is an important value fordetermining the bulk extinction coefficient of the blood. Accordingly,it is preferable to make the difference in thickness substantial. Inpreferred embodiments, the thickness of the second blood layer is atleast twice the thickness of the first blood layer. However, themathematical evaluation of the detected light signal is very sensitiveto the thickness of the blood layer, and thus, the difference inthickness (d_(b2)−d_(b1)) must be considered carefully. When thedifference in thickness of the blood layer is very small, the influenceof manufacturing tolerances can be dramatic, as very slight variances inmanufacturing of the chamber thickness can result in significantvariance in the measured values. On the other hand, as the difference inthickness of the blood layers increases, the strength of the signal ofdetected light diminishes exponentially in the channel with the widestgap thereby limiting the blood range over which measurements arepossible due to the required dynamic range of the receiver system.Accordingly, large thicknesses in the blood chamber can also result inunreliable data due to limits in measuring small signals. Thus, while itis beneficial for the thickness of the first and second blood layers tobe significantly different, each layer must fail within a relativelynarrow range of operable dimensions that are needed to collect accuratedata.

In order to take advantage of the above relationship of the twomeasurements, all of the terms from equation (7), except the termcorresponding to the blood e^(−a) ^(b) ^(d) ^(b) and the measured lightsignal i_(d), must be substantially identical for each of the twooptical paths. Thus, the intensity of the light being emitted along eachoptical path and the thickness and bulk extinction coefficient of all ofthe optical components (except the blood) between the light source andthe light sensor should be substantially identical for both opticalpaths.

The light intensity along each of the two optical paths can be madeequal by using a single light source with a known light pattern for bothof the paths. As illustrated in FIG. 5, the intensity of light beingemitted from a typical light source, such as the shown light emittingdiode and lens, is strongest along a central axis extending from thelight source. At angles that diverge from this axis, the intensity ofthe light decays. In FIG. 5, the solid line 42 is representative of thepolar intensity of the light being emitted from light source 40referenced in angle to the center of the source. At an arbitrarydistance from the source (Ds), the maximum intensity along the centralaxis is normalized to a value of 1.0. As can be seen in the figure, theillumination along the central axis 44 is strongest and the designatedintensity by the normalized arc 42 at this location is 1.0. In contrast,the light provided at the distance Ds from the source and at an angle of60° from the central illumination axis 44, corresponding to point 45 onthe normalized light intensity diagram, is half the maximum intensityand corresponds to an intensity of 0.5.

An important aspect illustrated by FIG. 5 is the symmetry of the decayin light intensity on either side of the illumination axis at a fixeddistance Ds. Embodiments of the present invention utilize thisequivalence to provide identical light intensity along both of theoptical paths being used in this optical system. Specifically, a singlelight source can be used to provide illumination along each of twooptical paths that are oriented at the same angle from the illuminationaxis and the same distance from the illumination source. Based on thelight radiation pattern shown in FIG. 5, the use of such symmetricaloptical paths provides light intensities that are reliably identical inintensity. This method is considerably more reliable than using twodifferent light sources that are merely rated at the same lightintensity, and it further eliminates the need to calibrate the system toaccount for any differences in intensity that are practically inevitableif using separate light sources. Further, use of a single light sourceremoves any issues with spectral difference that could arise whenseparate sources are used.

To make the bulk extinction coefficients identical for all of theoptical components along both optical paths, the optical blood monitoris designed to utilize a single blood chamber with areas thataccommodate blood layers of different thickness and receive light alongthe two separate optical paths. Aside from the differences in the twoblood layer sections, the components of the blood chamber are madesubstantially identical, to ensure identical bulk extinctioncoefficients of the static optical components within both paths.

FIGS. 6 and 7 illustrate an optical blood monitor 14 in accordance withan embodiment of the present invention. The blood monitor 14 includes anoptical blood sensor 34 and a blood chamber 32. The optical sensorassembly 34 includes at least one light emission element 4 that provideslight along two separate paths through the blood chamber 32. In atypical embodiment, the optical blood sensor assembly 34 may in factinclude multiple different light elements disposed at the same crosssection of the blood chamber with respect to the blood flow. Thedifferent light emission elements could thereby be configured to emitdifferent wavelengths of light, which is advantageous for collectingoptical blood data. An important aspect of the present embodiment,however, is that the respective wavelength light emission elements, emitlight along two different optical paths for making measurements of theblood.

The assembly 34 shown in FIGS. 6 and 7 includes a housing 35 configuredas a clamp or frame that receives the blood chamber 32 in a cavity 37disposed between two jaws 38. The jaws 38 can be biased toward oneanother to secure the blood chamber 32 in place, or can be configured inany way in order to fit securely around the chamber 32.

When the blood chamber 32 is disposed in the assembly 34, the lightemission element 4 is configured to emit light through the blood chamber32 along first and second optical paths 50, 52 that are disposed at anangle with respect to one another. The description of two elements orcomponents as being disposed “at an angle” to one another, as usedherein, identifies the components as being neither aligned nor parallel.Thus, the phrase “at an angle” precludes angles of 0 degrees or 180degrees, instead, as used herein, two components are disposed “at anangle” to one another if the components are angled at between 3 degreesand 177 degrees with respect to one another. Preferably, the particulargeometric relationship of the first and second optical paths isestablished to provide light along these paths at substantiallyidentical intensities. To achieve this similarity of light intensity,the two optical paths may be symmetrically disposed on either side of anaxis 54 of the light emission element 4 at substantially identicalangles β from the axis 54, as implied by the light intensity plot showin FIG. 5. Each of the optical paths 50, 52 is directed to a respectivelight sensor 8 disposed on the assembly housing 35. In the illustratedembodiment, the light emission element 4 is disposed on a first jaw 38of the housing 35 and the sensors 8 are disposed on the other jaw 38 ofthe assembly housing opposite the cavity 37 containing the blood chamber32.

During operation, the blood chamber 32 is disposed within the cavity 37of the optical blood sensor assembly 34 and receives a flow of bloodwhich is analyzed using the light emission element 4 and sensors 8. Theblood chamber 32 is shown in FIGS. 8 and 9 and includes an internalvolume 56 that is filled with blood through an inlet 58 and is drainedthrough an outlet 68. The internal volume 56 is specifically designed toprovide first and second blood layers 60, 62 of different thicknesswithin the respective optical paths 50, 52 of the light being emitted byelement 4 and received by sensors 8. The blood layers 60, 62 are formedby the geometry of the internal volume 64 of the blood chamber, which isdetermined by the shape of the body 66 of the blood chamber 32.Specifically, the blood chamber 32 includes first and second sections70, 72 that provide the respective blood layers 60, 62 within theinternal volume 56.

Preferably, the body 66 of the blood chamber 32 includes two opposingwalls 74, 76 that substantially define the shape of the internal volume56 and the orientation and thickness of the respective first and secondsections 70, 72. Each of the walls 74, 76 is oriented within the opticalblood sensor assembly 32 to correspond to one of the assembly's jaws 38.Thus, the first wall 74 is disposed on the side of the assembly 32 thatincorporates the light emission element 4 and the second wall 76 isdisposed on the side of the assembly 32 that houses the sensors 8.Moreover, the walls 74, 76 respectively provide the boundaries on thelight inlet side and light outlet side of the blood chamber sections 70,72. Specifically, the first wall 74, disposed on the light inlet side ofthe chamber near the light emitting element, includes a first region 74a that forms part of the first section 70 of the chamber and a secondregion 74 h that forms part of the second section 72 of the bloodchamber. Likewise, the second wall 76 has a first region 76 a thatdefines part of the first section 70 and a second region 76 b thatdefines part of the second section 72 of the blood chamber.

Advantageously, the two walls 74, 76 can be constructed as a continuouspiece so that the composition and thickness of each wall can reliably bemade the same in both respective first regions 74 a, 76 a and secondregions 74 b, 76 b. Moreover, the respective first and second regions ofeach wall 74, 76 can be fashioned to intersect the respective first andsecond optical paths 50, 52 at the same angle as illustrated in FIG. 7.Preferably, both of the walls 74, 76 are shaped so that the opticalpaths intersect the respective regions of the walls orthogonally. Theterm “orthogonal” is used herein to mean intersecting at approximately aright angle, for example at an angle between 85° and 95°. Due to theidentical intersection of the first optical path with each of the firstregions, and the identical intersection of the second optical path witheach of the second regions, the first region of each wall is disposed atthe same angle γ with respect to the second region of that respectivewall.

As a consequence of making each of the blood chamber walls 74, 76 as asingle piece, so that the respective first and second regions haveidentical thickness and composition, and by orienting the respectiveregions at the same angle with respect to the optical paths, the body 66of the blood chamber is formed to reliably have a substantiallyidentical influence on the light in each optical path 50, 52. Thus,while the thickness of the Hood layer is different for each section 70,72 of the blood chamber, the optical impact of the regions of the bloodchamber body that are disposed within the optical paths is substantiallyidentical. Consequently, the bulk extinction coefficient of the Hoodchamber itself is the same for each optical path.

Preferably, the optical blood sensor assembly is also constructed tohave a substantially identical influence on the light along each opticalpath 50, 52. This can be achieved by using the same principles as thoseapplied to the blood chamber, for example by making the lens 80 as asingle piece that intersects each of the optical paths at the sameangle. Likewise, the optical sensors 8 are preferably positioned at thesame distance from the second wall 76 of the blood chamber and areoriented at the same angle with respect to the respective optical path.Again, this similarity of the elements along each optical path allow theoptical blood monitor to have the same influence on the light along eachpath, so that the corresponding terms can be removed from the analysis,as explained above.

During operation, the optical blood monitor 14 is used to determineseveral blood parameters based on signals provided by the two lightsensors 8. The blood being removed from the patient for hemodialysistreatment is diverted to the blood monitor 14 before being returned tothe patient. Within the blood monitor 14, the blood is pumped throughthe internal volume 56 of the blood chamber 32 where the first andsecond blood layers are formed. At least one light emitting element 4 isoperated by a controller 90, as shown in FIG. 10, to provide a lightsignal along two optical paths that respectively pass through each ofthe first and second blood layers 60, 62. The light projected along eachoptical path is subsequently received by respective light sensors 8disposed in each path. Each of the light sensors produces a signal thatis indicative of the influence of the blood within the respective layeron the intensity of the light. The signals are passed to the controller90, which evaluates the signals to determine the bulk extinctioncoefficient of the blood α_(b) at each of the wavelengths, as explainedin detail above. Based on the bulk extinction coefficient α_(t), ratiosand the appropriate wavelengths, the controller 90 is able to determinevarious blood parameters, such as hematocrit, estimated hemoglobin,oxygen saturation and change in blood volume, which are then presentedon a display 92.

All references, including publications, patent applications, andpatents, cited herein are hereby incorporated by reference to the sameextent as if each reference were individually and specific-allyindicated to be incorporated by reference and were set forth in itsentirety herein.

The use of the terms “a” and “an” and “the” and “at least one” andsimilar referents in the context of describing the invention (especiallyin the context of the following claims) are to be construed to coverboth the singular and the plural, unless otherwise indicated herein orclearly contradicted by context. The use of the term “at least one”followed by a list of one or more items (for example, “at least one of Aand B”) is to be construed to mean one item selected from the listeditems (A or B) or any combination of two or more of the listed items (Aand B), unless otherwise indicated herein or clearly contradicted bycontext. The terms “comprising,” “having,” “including,” and “containing”are to be construed as open-ended terms (i.e., meaning “including, butnot limited to,”) unless otherwise noted. Recitation of ranges of valuesherein are merely intended to serve as a shorthand method of referringindividually to each separate value falling within the range, unlessotherwise indicated herein, and each separate value is incorporated intothe specification as if it were individually recited herein. All methodsdescribed herein can be performed in any suitable order unless otherwiseindicated herein or otherwise clearly contradicted by context. The useof any and all examples, or exemplary language (e.g., “such as”)provided herein, is intended merely to better illuminate the inventionand does not pose a limitation on the scope of the invention unlessotherwise claimed. No language in the specification should be construedas indicating any non-claimed element as essential to the practice ofthe invention.

Preferred embodiments of this invention are described herein, includingthe best mode known to the inventors for carrying out the invention.Variations of those preferred embodiments may become apparent to thoseof ordinary skill in the art upon reading the foregoing description. Theinventors expect ski lied artisans to employ such variations asappropriate, and the inventors intend for the invention to be practicedotherwise than as specifically described herein. Accordingly, thisinvention includes all modifications and equivalents of the subjectmatter recited in the claims appended hereto as permitted by applicablelaw. Moreover, any combination of the above-described elements in allpossible variations thereof is encompassed by the invention unlessotherwise indicated herein or otherwise clearly contradicted by context.

1. A method of optically monitoring a blood constituent, the methodcomprising: filling an internal volume of a blood chamber with blood soas to provide first and second blood layers within respective first andsecond optical paths of a light source, the second Hood layer having athickness along the second optical path that is substantially greaterthan a thickness of the first blood layer along the first blood path;emitting light of substantially identical intensities along the firstand second optical paths so as to pass the light through the respectivefirst and second blood layers within the Hood chamber; capturing lightpassing through the first and second blood layers using respective firstand second light sensors respectively disposed in the first and secondoptical paths; comparing the captured light; and determining acharacteristic of the blood constituent from the captured light.
 2. Themethod of claim 1, wherein the comparing includes evaluating a ratio ofthe captured light passing through the blood layers with respect to adifference in thickness of the blood layers.
 3. The method of claim 2,wherein the comparing includes ignoring an influence of at least oneoptical component disposed along the first and second optical paths onan intensity of the captured light.
 4. The method of claim 1, whereinthe blood constituent is a hematocrit value.
 5. The method of claim 4,further comprising estimating a hemoglobin value from the hematocritvalue.
 6. The method of claim 1, wherein the blood constituent isoxygen.
 7. An optical blood monitor for use in a hemodialysis systemoperable to monitor at least one blood constituent, the optical bloodmonitor comprising: a blood chamber including a body defining aninternal volume for receiving blood to be monitored by the hemodialysissystem, an inlet for supplying blood to the internal volume, and anoutlet for withdrawing blood from the internal volume; and an opticalblood sensor assembly including a light source that emits light alongfirst and second optical paths, the first optical path extending throughthe blood chamber to a first sensor and passing through a first sectionof the internal volume of the blood chamber that has a first thickness,and the second optical path extending through the blood chamber to asecond sensor and passing through a second section of the internalvolume of the blood chamber that has a second thickness, the secondthickness being substantially greater than the first thickness.
 8. Theoptical blood monitor recited in claim 7, wherein the light sourceincludes a light element emitting light about an axis, and wherein thefirst and second optical paths are disposed at an angle with respect toeach other and are symmetrically disposed about the axis of the lightelement such that an intensity of the light emitted along the firstoptical path is substantially equal to an intensity of the light emittedalong the second optical path.
 9. The optical blood monitor recited inclaim 7, wherein the light source includes a means for emitting light ofsubstantially equal intensity along the first optical path and thesecond optical path.
 10. The optical blood monitor recited in claim 7,wherein the first section of the internal volume of the blood chamber isdisposed between a first wall and a second wall of the blood chamberbody, the first and second walls each having a region that orthogonallyintersects the first optical path, and wherein the second section of theinternal volume of the blood chamber is disposed between the first walland the second wall and the first and second walls each have a regionthat orthogonally intersects the second optical path.